Cleaning And Sterilization Protocol - Arsenal Ankle Plating System | Enovis

1. CLEANING AND STERILIZATION PROTOCOL ARSENAL ANKLE PLATING SYSTEM CLEANING Non-sterile products must be carefully and thoroughly cleaned prior to sterilization. Trained personnel must perform cleaning and mechanical inspection prior to sterilization. Compliance is required with the equipment manufacturer’s user instructions (manual and/or machine cleaning, ultrasound treatment, etc.) and recommendations for chemical detergents. System Instrumentation Disassembly Instructions: The provided Depth Gauges should be properly disassembled prior to cleaning. The following instructions demonstrate how to properly disassemble the provided Depth Gauges prior to cleaning and then reassemble: 1. To remove the cone piece without wire damage, tap the back of the depth gauge firmly on a table. DO NOT REMOVE THE ATTACHED WIRE. 900-06-023 Rev A April 2022 Transfer parts into automated washer (STERIS® Reliance Genfore) for processing using the following parameters: Phase Recirculation Time 9. Temperature Detergent Type and Concentration N/A Pre-wash 1 Enzyme Wash Wash 1 02:00 Cold tap water Enzolâ 1 oz/gal Prolysticaâ 2X Neutral 1/8 oz/gal N/A N/A 02:00 Hot tap water 02:00 65.5°C Rinse 1 Drying 01:00 15:00 Hot tap water 90°C 10.Visibly inspect for remaining soil on part 11.If the part is not visibly clean, repeat steps 1-10 Recommended Manual Cleaning Instructions: 1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation 6. Allow articles to dwell in detergent bath for 1 minute 7. Remove parts from bath and rinse using reverse osmosis/deionized (RO/DI) water 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable 9. Allow parts to air dry. A clean lint-free cloth may be used to aid in drying 10.Visibly inspect for remaining soil on part NON-STERILE PRODUCT STERILIZATION DJO Implant Systems can be packaged non-sterile and therefore, must be sterilized prior to surgical use. Use of the sterilizer shall comply with the manufacturer’s user instructions. The user facility must thoroughly clean and disinfect instruments prior to sterilization per standard hospital procedures. Non-sterile devices are serializable by steam sterilization (autoclaving). The following parameters should be followed: Sterilization Method Condition Temperature Time Recommended Dry Time * The system shall be packaged for sterilization by double wrapping in an FDA cleared wrap and wrapping techniques outlined per ANSI/AAMI ST79, then adhered with FDA cleared chemical indicator autoclave tape. Note: Do not stack trays during sterilization. 2. To reassemble after cleaning, pull the slide back through the body to protect the wire and snap the cone piece onto the body. The provided Drill Towers should be properly disassembled prior to cleaning. The following instructions demonstrate how to properly disassemble the provided Drill Tower prior to cleaning and then reassemble: 1. To disassemble un-screw the insert from the outer sleeve. 2. To reassemble after cleaning, insert the inner sleeve into the outer sleeve and screw clockwise. 900-06-023 Rev A 900-06-023 Rev A Instrumentation Cleaning Instructions DJO recommends the following cleaning and sterilization instructions: Recommended Automatic Cleaning Instructions: 1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation 6. Allow articles to dwell in detergent bath for 1 minute 7. Remove parts from bath and rinse using reverse osmosis/deionized (RO/DI) water 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable Pre-Vacuum Steam Wrapped* 270°F (132°C) 4 minutes 60 minutes Please contact company for product inquiries and surgical techniques, or to report any adverse experience. This document is controlled by DJO. When downloaded, printed, and/or copied, this document becomes UNCONTROLLED and users should always check DJO’s website, www.djoglobal.com, to ensure they have the latest version. Trilliant Surgical 727 N Shepherd Drive Suite 100 | Houston, TX 77007 www.djoglobal.com/foot-and-ankle/ 1 of 1 900-06-023 Rev A